Senior Quality Lead, General Medicine (GMP)

Sanofi; Framingham (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Sanofi in Framingham seeks a Senior Quality Specialist General Medicine to ensure quality and regulatory compliance for products subcontracted to external entities. The role interfaces with North American sites, contract manufacturers, and cross-functional teams to uphold cGMP standards and regulatory submissions.

The position emphasizes collaboration with QA, regulatory, supply chain, and MSAT to strengthen quality strategy, resolve issues, and manage CAPAs within a dynamic global network.

Qualifications

• 1-3 years in Pharmaceutical Operations or Quality Operations with cGMP application.
• Experience in third party manufacturing Quality and Regulatory function.

Responsibilities

• Ensures Quality and Regulatory compliance of subcontracted products under cGMP and Sanofi directives.
• Manages quality system efficiency with subcontractors including complaints, deviations, change controls and non-conformities.
• Supports audits of External Manufacturing North America and manages CAPAs.
• Leads or participates in subcontractor audits and negotiates quality agreements.

Skills

cGMP knowledge

Quality systems

Project management

Communication skills

Education

Bachelor’s degree in Science or related field

Job description

Sanofi in Framingham seeks a Senior Quality Specialist General Medicine to ensure quality and regulatory compliance for products subcontracted to external entities. The role interfaces with North American sites, contract manufacturers, and cross-functional teams to uphold cGMP standards and regulatory submissions.

The position emphasizes collaboration with QA, regulatory, supply chain, and MSAT to strengthen quality strategy, resolve issues, and manage CAPAs within a dynamic global network.